NCT00990600已完成3 期
Adherence to a One Pill, Once-a-day Antiretroviral Regimen
A.O. Ospedale Papa Giovanni XXIII0 个研究点目标入组 212 人开始时间: 2008年4月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 212
- 主要终点
- Proportion of adherence to HAART
研究概览
简要总结
Primary objective of the study is:
To verify if simplification of the antiretroviral regimen, measured as the reduction of pill burden alone, may affect adherence rate of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Informed consent signed
- •Effective ongoing treatment (HIV-RNA < 50 copies/ml) for at least three months
- •Being on a stable HAART regimen based either on two possible drug associations:
- •3TC/FTC + TDF + EFV
- •FTC/TDF (fixed dose combination) + EFV
- •No previous documented virologic failure
排除标准
- •Childbearing or breastfeeding. Women of childbearing potential will be asked to adopt effective contraceptive methods or behaviours
- •Any ongoing grade 4 laboratory abnormality
结局指标
主要结局
Proportion of adherence to HAART
时间窗: 6 months
次要结局
- QoL (VAS scale) preferences of patients virologic and immunologic outcomes(6 months)
研究者
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